CELECOXIB capsule

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)

Fáanlegur frá:

Alembic Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

CELECOXIB

Samsetning:

CELECOXIB 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Celecoxib is indicated For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ]. For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ]. For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ]. For the management of the signs and symptoms of AS [see Clinical Studies (14.4) ]. For the management of acute pain in adults [see Clinical Studies (14.5) ]. For the management of primary dysmenorrhea [see Clinical Studies (14.5) ]. Celecoxib is contraindicated in the following patients: ·               Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions)to celecoxib, any components of the drug product [see Warnings and Precautions (5.7,   5.9) ]. ·               History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other   NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been        reported in such patients [see Warnings and Pr

Vörulýsing:

 Celecoxib capsules 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder.  NDC 62332-140-30    bottle of 30 capsules  NDC 62332-140-60    bottle of 60 capsules  NDC 62332-140-91    bottle of 1000 capsules  NDC 62332-140-08    carton of 80 (10 x 8) unit-dose capsules  NDC 62332-140-10    carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder. NDC 62332-141-30    bottle of 30 capsules  NDC 62332-141-60    bottle of 60 capsules  NDC 62332-141-31    bottle of 100 capsules  NDC 62332-141-71    bottle of 500 capsules  NDC 62332-141-91    bottle of 1000 capsules  NDC 62332-141-08    carton of 80 (10 x 8) unit-dose capsules  NDC 62332-141-10    carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder. NDC 62332-142-30    bottle of 30 capsules  NDC 62332-142-60    bottle of 60 capsules  NDC 62332-142-31    bottle of 100 capsules  NDC 62332-142-71    bottle of 500 capsules  NDC 62332-142-91    bottle of 1000 capsules  NDC 62332-142-08    carton of 80 (10 x 8) unit-dose capsules  NDC 62332-142-10    carton of 100 (10 x 10) unit-dose capsules     Celecoxib capsules 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder. NDC 62332-143-30    bottle of 30 capsules  NDC 62332-143-60    bottle of 60 capsules  NDC 62332-143-71    bottle of 500 capsules  NDC 62332-143-10    carton of 100 (10 x 10) unit-dose capsules  NDC 62332-143-14    carton of 126 (9 x 14) unit-dose capsules    Storage : Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

CELECOXIB - celecoxib capsule
Alembic Pharmaceuticals Inc.
----------
Medication Guide for Nonsteroidal
Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment and
may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may have
an increased risk of another heart attack if you take NSAIDs after a
recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth to
the stomach), stomach and intestines:
o anytime during use
o Without warning symptoms
o that may cause death
• The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of
NSAIDs
o taking medicines called “corticosteroids”, “antiplatelet
drugs”, “anticoagulants”,
“SSRIs” or “SNRIs”
o increasing doses of NSAIDs
o older age
o longer use of NSAIDs
o poor health
o smoking
o advanced liver
disease
o drinking alcohol
o bleeding problems
• NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions such
as different types of arthritis, menstrual cramps, and other types of
short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare pr

Vara einkenni

CELECOXIB - CELECOXIB CAPSULE
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELECOXIB CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CELECOXIB
CAPSULES.
CELECOXIB CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED
RISK OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN THE TREATMENT AND
MAY INCREASE WITH
DURATION OF USE. (5.1)
• CELECOXIB IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG)
SURGERY. (4, 5.1)
• NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR
INTESTINES, WHICH
CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10) 04/2021
Warnings and Precautions (5.11) 04/2021
INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older
(1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Acute Pain (AP) (1.5)
• Primary Dysmenorrhea (PD) (1.6). (1)
DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent
with individual patient treatment goals.
(2.1)
• OA: 200 mg once daily or 100 mg twice daily. (2.2, 14.1)
• RA: 100 mg to 200 mg twice daily. (2.3, 14.2)
• JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice
daily in patients more than 25 kg. (2.4,
14.3)
•